CANagliflozin In DIAlysis Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2026-02-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of this exploratory study is to investigate specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis and visualize this by the use of 18F- canagliflozin.

Secondary objectives 2

1. To investigate 18F- canagliflozin binding in specific regions of interest: The proximal tubule of the kidney Cardiac tissue Vascular tissue Brain tissue
2. To compare whether tissue distribution is different between dialysis patients that have and that do not have residual diuresis.

Conditions and MedDRA coding

Chronic Kidney disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1) Dialysis for more than 3 months both HD and PD (5 also with residual diuresis) 2) Age ≥18 years of age 3) Willing to sign informed consent

Exclusion criteria 1

1. 1) Mentally incapacitated subjects (i.e. not able to sign informed consent) 2) Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years. 3) Pregnant women and women of child-bearing potential who are not using reliable contraception 4) Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening 5) Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be interrupted 1 week prior to the first study day till the end of the second study day 6) History of hypersensitivity to canagliflozin or another SGLT2 inhibitor 7) Severe claustrophobia 8) History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. 9) Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months Pancreatic injury or pancreatitis within the last six months Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 10) Established peripheral arterial disease 11) Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission < 3 months before inclusion 12) People using digoxin 13) Patients with an active malignancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The overall percentage of receptor occupancy.

Secondary endpoints 2

1. The percentage of receptor occupancy in the specific regions of interest.
2. The overall percentage of receptor occupancy compared between dialysis patients that have and that do not have residual diuresis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Prof dr. H.J. Lambers Heerspink

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Prof dr. H.J. Lambers Heerspink

Third parties 5

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications